Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed.

This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer

NCT00002519

Lung Cancer

COMPLETED PHASE1

Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

NCT00020007

Lung Cancer Metastatic Cancer

COMPLETED PHASE1

A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

NCT00461110

Non Small Cell Lung Cancer

TERMINATED PHASE1

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors

NCT00499291

Cancer

WITHDRAWN NA

Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC

NCT00001450

Carcinoma, Non-Small-Cell Lung Lung Neoplasms

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paclitaxel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver, and renal function
* Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
* Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
* Measurable disease with obstruction into the airway
* Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
* Patients undergo recanalization procedure of tumor during bronchoscopy
* Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization

Exclusion Criteria

* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
* Uncontrolled infection
* Presence or recent history of any systemic disorder or conditions, such as:

* uncontrolled hypertension
* type 1 diabetes
* severe pulmonary hypertension
* acute kidney injury
* stroke (within the last 6 month)
* myocardial infarction (within the last 3 months)
* Individuals with neurological, mental or psychiatric disorders
* Concurrent participation in another study involving investigational drugs or investigational medical devices
* Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
* Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media
* Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation
* Any intraoperative complications that per the investigator's judgment increase the risk to the patient.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No